Rule 2 - Definitions and Interpretations - Cost Accounting Records (Pharmaceutical Industry) Rules, 2011

1 [2. , Definitions and Interpretations In these rules, unless otherwise requires,‐‐‐ (a) Act means the Companies Act, 1956 (1 of 1956); (b) bulk drugs means any pharmaceutical, chemical, biological or plant product including its salts, esters, stereo‐isomers and derivatives, which are used as such or as an ingredient in any formulation and shall include any bulk drug included in any bona fide Allopathic, Ayurvedic, Homeopathic, Sidha or Unani (Tibb) systems of medicine; (c) compliance report means the compliance report duly authenticated and signed by a cost accountant in the specified form of compliance report; (d) Cost Accountant for the purpose of these rules means a cost accountant as defined in clause (b) of sub‐section (1) of section 2 of the Cost and Works Accountants Act, 1959 (23 of 1959) and who is either a permanent employee of the company or holds a valid certificate of practice under sub‐section (1) of section 6 and who is deemed to be in practice under sub‐section (2) of section 2 of that Act and includes a firm of cost accountants; (e) Cost Accounting Standards means the standards of cost accounting, issued by the Institute; (f) cost records means books of account relating to utilisation of materials, labour and other items of cost as applicable to the production, processing, manufacturing or mining activities of the company; 2 [ (g) Form A-XBRL means the form prescribed in these rules for filing compliance report and other documents with the Central Government in the electronic mode and in the manner prescribed under rule 6 of the Companies (Filing of Documents and Forms in Extensible Business Reporting Language) Rules, 2011 ] 3 [ (h) Form-B means the form of the compliance report and includes Annexure to the compliance report and further includes the data or information required to be filed with the Central Government in the manner prescribed under rule 6 of the Companies (Filing of Documents and Forms in Extensible Business Reporting Language) Rules, 2011 ] (i) formulations means any medicine processed out of or containing one or more bulk drugs with or without the use of any pharmaceutical aids for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease in human beings or animals and shall include any medicine included in any bona fide Allopathic, Ayurvedic, Homeopathic, Sidha or Unani (Tibb) systems of medicine; (j) Generally Accepted Cost Accounting Principles means the principles of cost accounting issued by the Institute; (k) Institute means the Institute of Cost and Works Accountants of India constituted under the Cost and Works Accountants Act, 1959 (23 of 1959); (l) pharmaceutical activities means production, processing, or manufacturing of bulk drugs or formulations and includes the meaning assigned to them under the Drugs (Prices Control) Order 1995 as amended from time to time, or included under Chapters 29 and 30 of the Central Excise Tariff Act, 1985 (5 of 1986), and further includes the intermediate products and articles or allied products thereof; (m) product means any tangible or intangible good, material, substance, article, idea, know‐how, method, information, object, service, etc. that is the result of human, mechanical, industrial, chemical, or natural act, process, procedure, function, operation, technique, or treatment and is intended for use, consumption, sale, transport, store, delivery or disposal; 4 [ (n) Product or Activity Group means the product or activity groups notified vide S.O. 1747(E), dated the 7th August, 2012 ] (o) turnover means total turnover made by the company from the sale or supply of all products or services during the financial year and it includes any turnover from job work or loan license operations and the subsidies or grants or incentives received but does not include any non‐operational income; (p) all other words and expressions used in these rules but not defined, and defined in the Act and rules made under clause (d) of sub‐section (1) of section 209 of the Act shall have the same meanings as assigned to them in the Act or rules, as the case may be. ] -------------------- Notes:- 1. Inserted vide Notification G.S.R. 874 (E)., dated 07/12/2011 2. Substituted vide Notification No. G.S.R. 863(E) dated 30-11-2012 w.e.f. 02-12-2012 before it was read as (g) Form‐A means the form specified in these rules for filing compliance report and other documents with the Central Government in the electronic mode; 3. Substituted vide Notification No. G.S.R. 863(E) dated 30-11-2012 w.e.f. 02-12-2012 before it was read as (h) Form‐B means the form of the compliance report and includes Annexure to the compliance report; 4. Substituted vide Notification No. G.S.R. 863(E) dated 30-11-2012 w.e.f. 02-12-2012 before it was read as (n) product group in relation to tangible products means a group of homogenous and alike products, produced from same raw materials and by using similar or same production process, having similar physical or chemical characteristics and common unit of measurement, and having same or similar usage or application; and in relation to intangible products means a group of homogenous and alike products or services, produced by using similar or same process or inputs, having similar characteristics and common unit of measurement, and having same or similar usage or application;